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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
510(k) Number K162227
Device Name STA® - Liatest® D-Di
Applicant
Diagnostica Stago
3 Allee Theresa
Asnieres Sur Seine,  FR 92600
Applicant Contact Arnaud Berthier
Correspondent
Donawa Lifescience Consulting
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact Carlo d'Alessandro
Regulation Number864.7320
Classification Product Code
DAP  
Date Received08/08/2016
Decision Date 12/10/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01221805
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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